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QUESTION: Don't worry. ANSWER: So, yes, we have this, sort of -- what I thought wa s that the ALT test was probably the more effective. Yes, you get a better coverage if you put the two together, but, you know, at the time, there seemed to be a fairly strong view that we shouldn't introduce it. I should have st...
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QUESTION: Well, we'll move next to the topic where you did st and up and say that you should, and that's the question of hepatitis C screening, Dr Lloyd. Now, there's quite a number of documents I want to look at with you on this issue. We'll go throug h them in a largely chronological order. I'm going t o as...
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QUESTION: If we go over the page, we can see that there's a heading "Correlation with the Surrogate Markers f or [non-A, non-B hepatitis]". I'm not proposing to go to that, but just note that that's there. Then if we go to the third page, bottom of the page, there's a section on costs. ANSWER: Mm-hm.
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QUESTION: You refer to the costs per sample for the kit and s ay: "It looks likely that this test will soon be required in the UK. The cost of testing will be in the order of £200,000 -- £230,000 [per annum]. We will lose about 600 donors from our present panel a nd will have to destroy at least 600 donations in...
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QUESTION: -- and these are costs to the -- ANSWER: Yes, in Newcastle.
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QUESTION: -- northern Region -- ANSWER: Yes, this is -- this was me looking at what I'd see n and heard at the meeting and trying to translate it into what it was going to mean for our Centre.
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QUESTION: Were there other Regional Transfusion Directors at this lecture or meeting, as far as you can recall? You may have no memory at all of it. ANSWER: I can't, no, I can't. I can't recall, no, I'm sorr y.
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QUESTION: If we go over the page, we've got the "Summary": 5 "A non-A, non-B Hepatitis ... has been characterised and termed Hepatitis C virus." Then I don't propose to read out the rest of that paragraph. If we go to the third paragraph, you say th...
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QUESTION: -- for the first year. So it looks from this as though, as at July 1989, you were effectively plann ing ahead, both in terms of what kind of funding might need to be put in place, and what might need to be done to ensure that there wasn't a significant loss of donors without them being replaced; is th...
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QUESTION: Then if we look at NHBT0000188_008. This is a lett er from you, 20 July 1989, so a couple of weeks after you've attended -- ANSWER: Yes.
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QUESTION: -- that meeting, to the director of management services at the Northern Regional Health Authority, headed "Non-A Non-B Hepatitis". You say this in th e first paragraph: "The problem of Non-A Non-B Hepatitis has been with us for many years. This disease is transmissi ble by blood but no test has been a...
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QUESTION: Then if we go over the page, we can see you set out in the first paragraph costs and some of the implicati ons in terms of loss of donors and loss of donations an d what would need to be done, and then the next paragraph you give not a detailed estimate but an estimate of the total figure in the first ...
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QUESTION: So what was it that prompted you to make this relatively early contact with your Regional Health Authority, and what then happened in terms of your dialogue with the Health Authority? ANSWER: Well, the fact that we -- this was quite a big, you know, step to undertake. In the overall terms of t he NHS,...
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QUESTION: And we don't, I think, have the details of your further discussions with the Health Authority in documentary form, but you tell us in your statement you kept the Regional Health Authority informed as time went on, and the result, as I understand it, w as that when we get to 1991, and we'll look at what ...
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QUESTION: Now if we just then, however, go back to 1989, I ju st want to pick matters up in November 1989, with NHBT0005043. Now, these are the minutes of a meeting of the Advisory Committee on the Virological Safety of Blo od, 6 November 1989. You weren't, of course, on this committee, and I think we see obviou...
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QUESTION: And as I understand it, your and your colleagues in the regional Transfusion Service did not at the tim e see these documents; is that correct? ANSWER: Oh yes, absolutely. I think I said in my witness statement, if I had seen some of this or known some of this, I might have taken a somewhat stronger li...
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QUESTION: And of course -- ANSWER: And it wasn't transmitted by -- sorry, I was going to say, as far as I recall, Dr Gunson wasn't relaying the detail. And I think in a conversation with John Ca sh, I think, you know, he intimates that he can't actua lly pass some of this information on, it's not for publicati...
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QUESTION: And even though you wouldn't have seen it at the ti me, just to complete looking at this document, the discussion of the testing starts on page 4. Yes, NHBT0005043. And if we go now to page 4. I won't read it all out but we see paragraph 23 is Dr Gunson talking about a paper that had been prepared and...
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QUESTION: There's then, at paragraph 25, Dr Tedder giving the committee a summary of the history of the test. 26: "Dr Metters explained that although the Department must bear in mind the possible litigatio n that could rise from a prolonged delay in the introduction of general screening, the NHS Manageme nt Execu...
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QUESTION: I don't know whether, from your subsequent involvem ent in this issue, you have any particular observations or comments upon the stance being taken by the ACVSB a s at November 1989? ANSWER: It's the sort of -- a little bit of the beginning of -- of the almost a dance around the issue of the test. Th...
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QUESTION: Now that's November 1989, and we'll be exploring, Dr Lloyd, with other witnesses or through other witnesses I hope some of the events, particularly f rom a Department perspective, through into 1990. I want to pick things up in the middle of 1990. July of 1990 -- I don't, I'm afraid, have the document t...
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QUESTION: Then we can see Dr Gunson says he hopes this is: "... the final draft of the proposals for the proposed study comparing anti-HCV testing using Ort ho and Abbott test systems." Now, there had been some other studies and evaluations going on in the intervening period in which, I think, Newcastle was not ...
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QUESTION: If we look at NHBT0000042_045. So this is now a couple of months later, and Dr Gunson is sending a report on Phase I of this trial, which I think is how this particular evaluation was characterised, t o 95 Dr Rejman. We've got the report itself at NHBT0000190_030, if we just look briefly at that. Yes...
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QUESTION: We can see, if we go to page 3, paragraph 1.7: "All three RTCs reported that the tests were easy to perform and that the manufacturer's instructions were 'user-friendly'." There are then some specific comments made by yourself and the various -- and the other two centr es but I'm not going to take up t...
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QUESTION: Now, we know -- sorry, you froze for a moment then, Dr Lloyd, which is why I paused. ANSWER: Yeah.
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QUESTION: We know that by this time -- this is August 1990, w hen the study protocol, as it were, is being drawn up, and then October 1990, when it's being concluded -- we 7 know that there were a number of other countries wh ich had already introduc...
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QUESTION: Do you recall whether you were aware of that at the time or whether there was any discussion amongst Regional Transfusion Directors about the fact that the UK was arguably lagging behind other developed nations? ANSWER: I don't recall specific discussions. You know, one of the problems we've seen and...
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QUESTION: If we then look at another meeting of the Advisory Committee on the Virological Safety of Blood, from November 1990. NHBT0000073_018. So we can see the date of the meeting, 21 November 1990. If we go over the page we've got the heading "Hepatitis C testing": "The Chairman recalled the summing up of the ...
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QUESTION: But this message was never conveyed to you -- ANSWER: -- absolutely.
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QUESTION: -- is that right? ANSWER: I never saw this, never heard this. And looking back now, I'm rather -- I'm somewhat annoyed that this sort of information wasn't provid ed, I'm left in the dark, and I'm sorry about that.
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QUESTION: Then if we go over the page, there's two further paragraphs I want to read with you and then I want to look at some of the observations you make on it in your statement. So paragraph 18: "The Chairman summed up the discussion by saying there was agreement that the UK should introduce hepatitis C testi...
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QUESTION: Is there anything further you would wish to add on that issue and on the basis of what we see in those minutes, Dr Lloyd? ANSWER: No, I think that pretty much sums it up. You get t he feeling through these minutes that, yes, we're goin g to do it but there always seems to be a little "if" , a "but" be...
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QUESTION: Yes, so NHBT0000073_018, please, Sully, page 3. ANSWER: I hope I've got this right. I saw it briefly then and it reminded me.
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QUESTION: So paragraph 11 should be on your screen, Dr Lloyd. ANSWER: Okay, yes. In that highlighted section in the midd le, we see: "Both Dr Gunson and Dr Mitchell felt that if the results of the pilot study giving 6 true positives out of 10,000 donors were borne out in practice then counselling would be manag...
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QUESTION: Then going through this chronologically, I'm going to ask you to look next at a document from early January 1991, not a document you would have seen at the time. It's PRSE0002858, these are headed "JDC Notes of NBTS/SNBTS Management Meeting (7th January 1991)". So these are Dr Cash's own no tes 104 o...
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QUESTION: If we go to the second page and pick it up at paragraph 5, "HCV Donation Testing", Dr Cash has recorded here: "HG [that's Dr Gunson] conveyed his concern that DOH has still not decided on a start date. It now seemed probable that May/June 1991 would be the earliest possible. "2. HG advised that he b...
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QUESTION: "The issue is one of DOH's disinclination to fund centrally and insist on cross charging -- ie increasing the unit cost of blood supplied to hospitals." Now, two questions arising out of that, Dr Lloyd. The first is, as I understand your evidence, you had not been working on any assumptio n that the ...
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QUESTION: Secondly, did Dr Gunson ever communicate to you the belief that is recorded here by Dr Cash that this w as an issue relating to the Department of Health tryin g to find the mechanism for finding the money? Was t hat something ever communicated to you at the time as a potential cause of the hold-up? ANS...
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QUESTION: Then, if we, still in -- ANSWER: I do note, if I may just interject there?
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QUESTION: Yes. ANSWER: Under the same section 5, item 3: "...[frozen screen]... requested a more definitive operational description for a 'start dat e' ..." It gives the impression that John Cash and the Scottish Transfusion Service are unhappy about this vague issue of a start date, that they're not happy with a ...
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QUESTION: So if we then move a little further on in January 1 991 to NHBT0000076_006, so this is a memo from Dr Gunso n, 22 January '91 to the Regional Transfusion Director s England and Wales so you would have received this, 106 Dr Lloyd. ANSWER: Yes.
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QUESTION: Paragraph 1: "The Department of Health have agreed that routine testing of all blood donations for anti-HCV can be put into operation. "2. I have been asked to try and ensure that testing starts simultaneously in RTCs in England an d Wales and that it is co-ordinated with commencement of testing in S...
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QUESTION: And then we know that other Regional Transfusion Directors also responded to Dr Gunson's request wit h a range of different potential commencement dates. The next, I think, global, communication from Dr Gunson to RTDs is NHBT0000191_077. Again, we can see this is a round-robin letter from Dr Gunson, 15...
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QUESTION: Do you ever any recollection of what your reaction or feelings were, bearing in mind you were ready to st art at this point in time, on 1 April, being told it wa s going to be 1 July? ANSWER: I was upset. I thought this was unnecessary. And it's -- there's nothing there that tells you why it's 1 Jul...
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QUESTION: "... had not yet been finalised. Members agreed it was important for proper evaluation of the Ortho an d Abbott 1&2 tests to be carried out before RTCs deci ded which test they would adopt." So this is the decision or recommendation of the ACVSB that before testing is introduced, there should now be a f...
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QUESTION: -- but that information -- ANSWER: -- no.
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QUESTION: -- came to your attention. We'll look at how in du e 111 course. But in broad terms, what was -- what's you r view of the suggestion that there should now be thi s further evaluation involving the second general election tests? ANSWER: Sorry, can you remind me the date, was this Februar y 1991?
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QUESTION: We'll do that. ANSWER: Yeah. It's a confusing statement: "... likely availability of second generation tests ..." Saying we're not sure when, it's only the "likely availability". Then: "... Operational factors ... might influence decision [of] RTCs as to which screening test to choose." That's ver...
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QUESTION: Dr Lloyd, we lost you there for a -- ANSWER: Either the minutes or -- okay. I was repeating myself.
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QUESTION: No, no, we lost you for a couple of seconds, so I j ust wanted to check we didn't miss anything significant . ANSWER: Yes.
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QUESTION: You said this: 13 "So now we're suggesting that you might have a situation, once the second generation test eventually becomes available, that some centres wil l choose to use first generation tests ..." And then we missed possibly just a fe...
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QUESTION: And then you said, "doesn't make any sense". ANSWER: Okay.
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QUESTION: So could you just repeat that point? ANSWER: Certainly. This minute suggests that the situation might be after this testing that some transfusion centres wo uld choose to use the first generation test, and some centres would choose to use the second generation test. And that makes no sense. Either t...
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QUESTION: And it may be that we will, with other witnesses, n eed to explore the whole minutes, but I'll just flag up that in paragraph 7 it says: "The Chairman summed up the view of the Committee following discussion ..." And then if we go over the page, there's three 114 bullet points there, and then over the p...
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QUESTION: "The start date for HCV testing set by the National Directorate is currently 1st July. However two Centres in particular are unhappy about this. One of them is Cambridge." Now, that would suggest you'd had some discussions or communications with some other centr es. Do you recall what the unhappiness ...
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QUESTION: No, you're absolutely right. ANSWER: -- I don't have documentation about that.
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QUESTION: I think Cambridge had indicated it would be ready b y October so that might suggest the unhappiness -- 17 ANSWER: Yes.
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QUESTION: -- from their perspective. You then refer to the Procurement Directorate "looking at FOUR potential suppliers of HCV kits". That, I think, is a reference not to a Northern Reg ion Procurement Directorate but to the NHS Procurement Directorate or DoH Procurement Directorate. ANSWER: Yes. That's correct....
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QUESTION: You say there: "... want ... several firms involved to enable them to obtain lower prices for the kits." Do you recall what the source of your information was in relation to that? ANSWER: No, I don't. I don't know how I came by that. I would imagine -- I mean, that's the sort of thing that ...[frozen...
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QUESTION: Sorry, we lost you again, Dr Lloyd. ANSWER: Okay. No, I'll wait for a moment. Okay. I don't know where I got that information from, I'm sorry. I think I was waffling a bit then. I don't know where it came from.
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QUESTION: Then you say: "I suggest we proceed as intended, as soon as a second generation kit is available." So that's 14 March. If we then just still in 118 March go to NHBT0000062_039. Now, this is an inter nal Department of Health memo, 8 March 1991, referring to the ACVSB decision to extend HCV screening ...
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QUESTION: Do you have any recollection of Dr Gunson exploring with you Newcastle's capability to carry out the additional work? Because, as I understand it, it w as anticipated that Newcastle would be one of the cent res evaluating the second generation kits. ANSWER: No, I don't recall him discussing it with us....
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QUESTION: I'm not going to go to the next document, which is a letter from the Procurement Directorate, to Dr Gunson, on 21 March 1991, which sets out how it was proposed this second round comparative evaluation should be undertaken at Newcastle, North London and Glasgow, but the reference for the transcript is N...
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QUESTION: -- you'll see: "You will recall that in my letter to you in 15th February I suggested that 1st July 1991 might be an appropriate date to commence anti-HCV screening of blood donations." Then he refers to the availability of the second generation test kits, and also to the possibility o f other companies...
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QUESTION: -- or forward from July to September, however you w ant to characterise it. Had there been, as far as you' re aware, any discussion between Dr Gunson or anyone e lse from the National Directorate and Regional Transfus ion Directors, such as yourself, or did this come out o f the blue? ANSWER: This ca...
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QUESTION: In a nutshell, Dr Lloyd, what was your reasoning fo r going ahead in the way described here? ANSWER: Well, obviously I'd written it in my witness statement. We had the wherewithal to do the test. We had the -- funding was in place, we had the tests available. We had the equipment available. We had ...
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QUESTION: We can see you anticipated in that last sentence th at there might be some problems with the 124 National Directorate. Let's pick that up with a letter Dr Gunson wrote to you. NHBT0000062_054, please. And we go to page 3. So 29 April, Dr Gunson wrote to you. First paragraph refers to a telephone con...
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QUESTION: And then over the page, we see, the top of the page , he refers to the 'second-round' evaluation. Then t he next paragraph: "Unfortunately the timing stated in this letter slipped ..." And he explains that was the reason for his letter deferring the date to be aimed for as 1 September 1991. Then the...
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QUESTION: We can see your response at NHBT0000074_010. You say there: "When a common date of 1st July was circulated sometime ago, I made a decision to start testing in April 1991 so that we could be assured that not only were all issues of blood and blood components negative for the antibody but that all units ...
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QUESTION: Yes. ANSWER: Is it right for me to?
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QUESTION: It's, in terms of the mechanics of putting screenin g into operation, is this correct: routine testing of donations began on 24 April but there'd also be a period of needing to test what was held in stock and so on, and is that what feeds, then, into this last sentence, all units will have been tested fro...
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QUESTION: And then the way you've put it in your statement, a nd I don't think I need display it, it's just two sentences I wanted to read out: "A delay until July displayed me, and a proposed July until about 1st September was unacceptable. W e all knew that there were infectious donations in th e system that ...
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QUESTION: You also wrote to your Regional Health Authority an d you wrote a letter to your Regional Transfusion Director colleagues. I'm not going to go through those, I'll just read the references out so that others have a record of them. The letter to the Regional Health Authority, 30 April 1991, was NHBT000...
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QUESTION: Then Dr Ala wrote to you on 8 May, NHBT0000074_020. He says: "I am afraid your decision to commence testing before everyone else has come at a very inopportune moment, for it will seriously undermine the whole concept of establishing a National Service precisel y at the time when this proposal is being s...
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QUESTION: -- WITN6935001, page 95. You described this, at th e top of the page, as: "... a strange criticism to throw at Newcastle's decision ... given that Dr Ala had stated in respon se 33 to Dr Gunson's earlier request that they [in Birmingham] ...
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QUESTION: Yes. ANSWER: But those were things that had already been discuss ed extensively that we knew that we had a problem, and Dr Ala wasn't raising any complaints about starting testing. So that argument -- I think, in the heat of the moment, you know, people were throwing in arguments just because they felt...
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QUESTION: Then the third letter I wanted to discuss briefly w ith you was NHBT0000074_033. This was from Colonel Tho mas of the Army Blood Supply Depot, 17 May, third paragraph: "I must say that I was personally dismayed to learn that you were going to break ranks over the 134 agreed policy on the introduction...
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QUESTION: Then I want to ask you now to look at you letter th at you wouldn't have seen at the time, it was from Dr Cash to Dr Gunson, NHBT0000074_024, headed "The 135 Newcastle Saga: HCV Donation Testing". ANSWER: Yes.
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QUESTION: I just want to -- ANSWER: May I?
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QUESTION: Yes. ANSWER: May I just -- I'm sorry, I -- rather than come back to this after this document, may I just say something about the previous letters that I received?
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QUESTION: Of course. ANSWER: Obviously, I was, you know, fairly upset by the ton e of the letters but I think there were two letters t hat I received that and I'd like to point out were in a much more reasonable tone, and I think it's fair that I should say that the letters from Dr Martlew and Dr Mitchell in Sc...
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QUESTION: Thank you, Dr Lloyd. So I just really wanted to invite your attention here and any observation you have on the last sente nce of the first paragraph, where Dr Cash puts it in th ese terms: "... we should make every effort to maximise 136 this disaster to our corporate advantage." I wondered whether yo...
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QUESTION: Then just in relation to a response of the Departme nt of Health -- or, sorry, I should say a response of someone within the Department of Health, more accurately, NHBT0000062_054. This is a memo from Dr Rejman to Dr Metters, 30 April 1991. He says he encloses "a copy of a letter sent by Dr Gunson ... ...
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QUESTION: That's what Dr Rejman is referring to. If we go back to the first page, please, in Dr Rejman's memo. Point 2, he says: "This gives details of routine anti-HCV screening at Newcastle RTC which commenced last wee k. "3. This action was taken despite the agreed policy by the ACVSB that screening should s...
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QUESTION: Then Dr Rejman's observation in paragraph 5, and obviously we can ask him about this, but it says: "This action has caused problems in that the other major competitor company feels disadvantaged, and has also caused problems in Scotland. "6. We are waiting for written reasons as to why this action was ...
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QUESTION: Were you surprised that the introduction by you of a measure designed to improve patient safety trigge red such a response from others? ANSWER: When I decided to introduce the test, I knew there was 140 going to be a backlash. Or I was pretty sure. And what I -- when I re-read those letters, what I n...
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QUESTION: Just a handful of further questions about the correspondence and so on at this time. First of all, NHBT0000074_026. You wrote to Dr Gunson on 9 May 1991. You referred to Dr Contreras's letter and said your impression was "that there was a concerted attempt to obtain funding from the Department of Heal...
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QUESTION: Now, one of the things that happened next, and we c an pick this up at NHBT0000192_024, was the suggestion that your action would be regarded as a trial and n ot the commencement of routine testing. So we can see this is a letter from Dr Gunson to all RTDs, 9 May 1991. We can pick it up, I think, bottom ...
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QUESTION: If we just go to the third page of this document, please, Sully. This a brief to answer press querie s, "Line to Take" being set out by Dr Gunson. I'm not going to go through all of it but if we can just go towards the bottom of the page, just ab ove paragraph 6 "Legal Liability", there's a heading "I...
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QUESTION: Then if we look at the penultimate paragraph on thi s page, beginning "The second of these valid criticisms", so this is about not giving other cent res adequate warning, you say: "The second of these valid criticisms resulted from my view that had I informed everyone earlier, pressure would have been ...
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QUESTION: I think we lost a few seconds of your -- ANSWER: Fortunately the -- yes. Yes, that's what I thought was would happen, would be that there would -- that the route would be from the Department of Health through to the Regional Health Authority, where the person I reported to would then tell me not to star ...
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QUESTION: And then if we can look at a memo you wrote in June of 1991 setting out your reflections. NHBT0000192_092. 18 June 1991. It's not to anyone. It reads as though this may be as it were a note to yourself, almost, for the record. ANSWER: It was, yes. It was a note to myself. I occasiona lly did that....
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QUESTION: I'm not going to read through the detail of it. Yo u refer to a meeting held in York. I think that was the Northern Region that had met. 147 If we look down at the -- ANSWER: I think it was on the -- 14 June, I think.
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QUESTION: Then if we look down the bottom of the page, just w ant to look at the last paragraph. You say this: "At the end of this meeting I felt confident that as a Centre we had made the right decision to proceed with Hepatitis C testing when we did. My o nly regret is that we didn't introduce it earlier. Th...
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QUESTION: Do you have a sense of how much earlier you could h ave introduced it on a local basis in Newcastle, given the other constraints about the way in which the ACVSB was taking its decisions and so on? ANSWER: There's a number of issues there. If you take the purely logistical issue, we had the wherewitha...
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QUESTION: Then we see Dr Gunson explains: "[He is] thinking of responding to Simon Pearl in terms roughly as set out above. I think it is important that our efforts [that's his and Dr Barbara's] correspond reasonably well." Then if we go to the report from Dr Gunson and Dr Barbara, or the statement, I should sa...
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QUESTION: Do you have any observations about what's set out there? ANSWER: Yes, as I said, the letter I sent to Dr Gunson referring to 1 July, I think I, as I said before, I was tying to protect my own back, a little bit, by sort of making out that I wasn't quite as forthrigh t in starting this testing when I di...
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QUESTION: Then the last part I wanted to ask you about in thi s document is on the last page. Last paragraph: "There is no doubt that Dr Lloyd's decision was not in the interest of the Service as a whole and w as 154 taken in the knowledge that he was flaunting the decisions of the Department of Health who had ...
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QUESTION: Then can I ask you -- and this is now just really o n a point of detail, rather than the issues of princi ple which we've been discussing, can I ask you to look at WITN6935035. This is a letter from Dr Collins, 3 January 1991, and it says -- it's a letter for donors who have been tested and whose test ...
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QUESTION: An alternative explanation could be -- sorry, you'r e frozen, Dr Lloyd, so I'll just wait until -- ANSWER: -- following on -- sorry.